Biostatistical Programming Senior Associate in Hyderabad,… - Jobeax
Vacancy description
Biostatistical Programming Senior Associate in Hyderabad, भारत
Amgen
Hyderabad, भारत
Amgen seeks a Biostatistical Programming Senior Associate in Hyderabad to perform statistical programming for clinical trials and regulatory submissions. The role involves SAS/R programming, dataset creation and validation, and collaboration with global cross-functional teams supporting integrated clinical development.
Responsibilities
Perform statistical analysis and reporting of clinical trial data using SAS and/or R
Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy studies
Generate and validate complex tables, listings, and figures for regulatory submissions
Develop statistical programming specifications and related regulatory documentation
Collaborate with cross-functional teams to develop and validate data quality check programs
Requirements
BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
Minimum 4 years statistical programming experience in clinical development environment
Proficiency in SAS/STAT packages and complex clinical trial data manipulation
Working knowledge of CDISC SDTM, ADaM, and Define standards
Familiarity with data quality and compliance check tools
Excellent oral and written English communication skills
Ability to manage multiple projects across therapeutic areas and work in globally dispersed teams
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